Kornimate/medical-research-clean huggingface dataset:
raltegravir vs. lopinavir/ritonavir, both in combination with truvada, in hiv+ treatment naive individuals

Conditions: HIV Infections

Summary: this program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with hiv-i infection who have not received prior antiretroviral therapy. all patients will receive concomitant therapy with truvada.

it is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in cd4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.

Eligibility criteria:
inclusion criteria: 1. documented hiv infection confirmed by western blot or hiv rna. 2. at least 18 years of age. 3. less than 1 week of prior antiretroviral therapy. 4. in the opinion of the investigator, patients should be clinically stable. patients may be on chronic suppressive therapy for opportunistic infections such as mac or cmv. 5. patients who are of reproductive potential agree to use an acceptable method of birth control throughout the study. acceptable methods include an intrauterine device (iud), diaphragm with spermicide, condoms, or abstinence. 6. hiv rna \> 5000 copies/ml. no restriction on cd4 cell count. 7. a negative urine pregnancy test on the day of initiation of therapy. exclusion criteria: 1. prior treatment with \>1week of antiretroviral therapy. 2. patient requires or is anticipated to require any of the prohibited medications noted in the protocol. 3. hiv rna \< 5000 prior to receiving therapy. 4. baseline resistance to any of the study regimen drugs on genotype testing. 5. patients with acute hepatitis due to any cause or clinically significant chronic liver disease. 6. patient with severe renal insufficiency defined as a calculated creatinine clearance at time of screening \<30ml/min, based on the cockcroft-gault equation which is as follows (and 0.85x this value for females): clcr(ml/min) = (l40-age) x weight (in kg)72 x serum creatinine (mg/dl). 7. patient has a condition (including but not limited to alcohol or other substance abuse) which in the opinion of the investigator would interfere with patient compliance or safety. 8. a female patient who is pregnant, breast-feeding, or expecting to conceive or donate eggs during the study; or a male patient who is planning to impregnate or provide sperm donation during the study is excluded. 9. inability to obtain signed informed consent from a patient age 18 or older. 10. patient has significant hypersensitivity or other contraindication to any of the components of the study drug. 11. patients who should be treated for hyperlipidemia as per ncepiii guidelines and patients who are currently receiving lipid-lowering therapy are excluded.

Keywords: raltegravir lopinavir
pretreatment with electroacupuncture to reduce discomfort

Conditions: Pain

Summary: the main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam.

to assess the efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy.

Eligibility criteria:
inclusion criteria: * adult patients referred for their first colonoscopy in the department of gi in sheba, tel hashomer exclusion criteria: 1. ages \ 75y 2. any prior gastrointestinal endoscopy. 3. history of colonic resection. 4. known or suspected stenosis of the colon. 5. pregnancy. 6. inflammatory bowel disease 7. neuropsychiatric disorders or receiving psychotropic drugs. 8. prior knowledge or experience of acupuncture.

Keywords: colonoscopy acupuncture pain
can high ventilation provide higher success rates in retrograde intrarenal surgery?

Conditions: Kidney; Mobile

Summary: rirs (retrograde intrarenal surgery) has been accepted as a first-line treatment option for urinary stones smaller than 2 cm and is generally performed under general anesthesia to manipulate respirator-related renal mobility. many surgeons prefer general anesthesia during rirs to minimize respiration-related renal mobility. standard mechanical ventilation settings were still inadequate to limit renal mobility and the surgeons tried to find the most effective ventilation mode to minimize renal mobility.

a standard general anesthesia protocol is given to all patients by the same anesthesiologist. a drager primus (germany) mechanic ventilator (mv) is preferred for general anesthesia. the mv will determine the tidal volume and respiration frequency according to the patient's age and weight with end-tidal co2 levels of 30-35 mmhg. standard ventilation mode is 8-10 ml/kg tidal volume and 10-15 respirations/min. during hv mode, the tidal volume will decrease to 6-8 ml/kg and the frequency will increase to 15-18 respirations/min. no changes are made in the inspiratory expiratory ratio (1:2), fio2, and positive end-expiratory pressure (peep) parameters. the ventilation mode of the mechanic ventilator (sv or hv) is determined via randomization software before the surgery. according to randomization, the anesthesiologist is informed about the ventilation mode but the surgeons are absolutely blind. a high ventilation mode is formed by increasing the respiration frequency and decreasing the study's tidal volume. the aim of the study was to evaluate the effect of this mode on the efficacy and safety of rirs.

Eligibility criteria:
inclusion criteria: patients who underwent rirs with kidney stones older than18 y.o exclusion criteria: patients younger than 18 years old patients with a known respiratory disease patients with a renal anomaly proximal ureteral stones, or stones with multiple locations the patients who underwent previous ipsilateral percutaneous nephrolithotomy and/or open renal surgery were excluded from the study.

Keywords: renal mobility urinary stone mechanic ventilation success status
study on the role of gamma delta t cells in sepsis immunosuppression and its molecular mechanism

Conditions: Sepsis

Summary: the purpose of the study is to evaluate the status and function of gamma delta t cells in peripheral blood of sepsis patients.

sepsis therapy is a prominent problem of the modern critical care medicine,and improving the level of sepsis treatment by immune intervention measures is a hot research topic with close attention.gamma delta t cells is considered as one new t lymphocyte subset in recent years,which playing an important role in resistance to infection,anti-tumor and immune regulating function in the body.first,we played attention to the status and function of gamma delta t cells in peripheral blood of sepsis patients including differentiation marker,subtype and production of related cytokine,and then the molecular mechanism of insufficient gamma delta t cells.at the same time the responsibility of gamma delta t cells of sepsis patients to certain bacteria and viral antigen and the regulation of gamma delta t cells on other natural immune cells including nk cells and mononuclear cells were studied to identify the status and role gamma delta t cells in sepsis immunosuppression by culture in vitro.further we studied the effect of specific stimulants on proliferation and activation of gamma delta t cells in patients with sepsis and also anti-infection acquired by gamma delta t cells,expecting as an entry point to explore new treatment strategy to sepsis.

Eligibility criteria:
inclusion criteria: * clinical symptoms of severe sepsis and septic shock * age over 18 years exclusion criteria: * preexisting autoimmune disease * patients received immuno-suppressive treatment in the previous 6 months * patients with chronic infection,e.g.tuberculosis,hepatitis or hiv infection,etc. * pregnancy

Keywords: sepsis gamma delta t cells immunosuppression
structured discharge and follow-up protocol for copd patients receiving ltot and niv

Conditions: COPD Exacerbation; Noninvasive Ventilation; Long Term Oxygen Therapy; Chronic Respiratory Failure

Summary: readmission to hospital is one of the most important problems in chronic obstructive pulmonary disease (copd) patients who developed chronic respiratory failure. patients receiving long-term oxygen therapy (ltot) and noninvasive ventilation (niv) constitute the most vulnerable group because of the need for comprehensive care. however, because of lack of health care support systems in turkey, many advanced copd patients are hospitalized due to preventable problems such as insufficient knowledge about the therapies, nonadherence to therapy and technical issues related to ltot/niv equipment. the aim of this multicenter randomized trial is to find out whether a structured discharge and follow-up protocol reduce the rate of unplanned, copd-related hospital readmissions over 90 days in patients receiving ltot or niv.

the study is planned with turkish thoracic society and global alliance against respiratory disease-turkey partnership and being carried out 10 centers throughout turkey. copd patients who are prescribed long-term oxygen therapy for hypoxemic respiratory failure and/or noninvasive ventilation for hypercapnic respiratory failure will be included in the study and will be randomized to either intervention or control arm. the intervention mainly consists of not only education about the disease and medications but also the education of the equipment and how to use it to have the best benefit. control arm patients will receive usual care, which consists of basic education of the patient about the therapies. the primary outcome of the study is readmission in 90 days.

Eligibility criteria:
inclusion criteria: copd patients who developed chronic respiratory failure and are eligible for long-term oxygen therapy (ltot) or noninvasive ventilation (niv) according to turkish national social security regulations definitions: copd: the diagnosis of copd is made according to gold criteria chronic respiratory failure: pao2\>60mmhg at room air and/or paco2\> 45 eligibility for ltot: 1. pao2 ≤ 55 mmhg or sao2 ≤ 88% under room air 2. pao2 value of 55-59 mmhg or sao2 ≤ 89% and cor pulmonale with hematocrit \>55 or p pulmonale in ecg or congestive heart failure. eligibility for niv: 1. paco2≥55 mmhg or 2. paco2 50 to 54 mmhg and nocturnal desaturation ≤ %88 for 5 minutes under 2lt/min nasal o2 therapy 3. paco2 50 to 54 mmhg and \>2 exacerbations within the last year exclusion criteria: 1. patients receiving ltot or niv for a different cause 2. patients who do not give consent 3. patients who are unable to be followed up regularly due to reasons such as living far from study center, lack of family support, unwillingness or inability to contact regularly. -

Keywords: copd exacerbation structured discharge readmission chronic respiratory failure
12 week study of the safety/efficacy of asenapine when added to lithium/valproate in the treatment of bipolar disorder (a7501008 / p05844 / mk-8274-017)

Conditions: Bipolar Disorder

Summary: this is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of bipolar i disorder.


Eligibility criteria:
inclusion criteria: * have bipolar i disorder, current episode manic or mixed * treated with lithium or valproic acid exclusion criteria: * have an unstable medical condition * clinically significant laboratory abnormality. * have a primary diagnosis other than bipolar i disorder.
standard balloon angioplasty versus angioplasty with a paclitaxel-eluting balloon for femoral artery in-stent restenosis

Conditions: Peripheral Vascular Disease

Summary: comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (sfa) using either a standard balloon (admiral xtreme, invatec) or a paclitaxel-eluting balloon (in.pact™ admiral, invatec).


Eligibility criteria:
inclusion criteria: 1. age \> 21 years old. 2. patient must sign informed consent form. 3. patient must agree to participate in the study and comply with follow-up requirements. 4. clinically, all patients must be in rutherford category 2 to 4. angiographic inclusion criteria: 5. planned angioplasty of in-stent restenoses (degree of stenosis 70-100%) within the sfa. the target lesion must not extend beyond the stent margins. in cases of two or more stenotic regions within the stented segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (\< 30%) segment of at least 2 cm in length between them. otherwise, they are considered a single lesion. in case of separate lesions, only the proximal lesion will be taken as the target lesion! 6. the length of the in-stent lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler). 7. the degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound. 8. the target lesion region starts at the origin of the sfa and ends distally at the femoropopliteal crossover (crossing by sfa of medial rim of femur in the pa projection). 9. patency (\< 50% stenosis) of popliteal artery and at least 1 infragenicular artery. exclusion criteria: general: 1. patient is currently participating in another clinical trial. 2. pregnancy or pregnancy planned during study duration. 3. life expectancy less than 1 year. 4. co-morbidities preventing study participation. 5. severe coagulation disorders. 6. current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel. 7. active gastric ulcer or gastrointestinal bleeding. 8. thrombotic occlusion of the target vessel within previous 4 weeks. 9. treatment of target lesion with laser or atherectomy devices. 10. dialysis dependency. 11. manifest hyperthyreosis. 12. known allergy against contrast agent that cannot be adequately controlled by usual premedication. 13. known heparin intolerance. 14. known paclitaxel intolerance. angiographic: 15. target lesion extends into the popliteal artery. 16. symptomatic untreated inflow lesion \> 50% in ipsilateral iliac arteries. pretreatment of iliac stenoses is possible. 17. sfa lesions \> 50% stenosis proximal and/or distal to the target lesion that require treatment. 18. target lesion extends beyond the stent margins.

Keywords: standard balloon angioplasty poba angioplasty with paclitaxel-eluting balloon superficial femoral artery
comparison of ultrasound-guided quadratus lumborum block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing cesarean section

Conditions: Quadratus Lumborum Block; Iliohypogastric/Ilioinguinal Nerve Block; Cesarean Section

Summary: the purpose of this study is to compare the analgesic effect of ultrasound-guided quadratus lumborum block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing cesarean section.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestation of at least 37 weeks * american society of anesthesiologists (asa) physical status i or ii * finish pfannenstiel section under combined spinal and epidural anesthesia exclusion criteria: * pruritus existed before the surgery * allergic to lidocaine, ropivacaine or dexamethasone
evaluating the use of the qidni/d hemodialysis system by subjects with end-stage renal disease

Conditions: Kidney Disease, End-Stage

Summary: the main goal of this clinical study is to evaluate the safety of the qidni/d hemodialysis system in patients with end-stage renal disease. the main question it aims to answer is: is the qidni/d safe for performing hemodialysis? participants will be subjected to one treatment of hemodialysis for up to 4 hours with the use of the qidni/d.


Eligibility criteria:
inclusion criteria: * subject has provided informed consent. * subject is at least 18 years and less than 75 years of age. * subject has end-stage renal disease adequately treated by maintenance dialysis and has been deemed stable for at least three months by his/her treating nephrologist. * subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min for conventional treatment or 200-250 ml/min for nocturnal hemodialysis treatment. * subject understands the nature of the procedures and the requirements of the study protocol. * subject is willing and able to comply with the protocol requirements and return to the treatment center for all required treatments and clinical evaluations. * subject has no childbearing potential or the subject affirms they are not pregnant. subject affirms using contraception measures to prevent potential pregnancies during the study period. exclusion criteria: * subject is unable to read english. * subject has dementia or lacks capacity for self-care. * life expectancy less than 12 months from first study procedure. * subject unable to understand or cooperate with the hemodialysis nurse and dialysis care team. * subject has a documented history of non-adherence to dialysis therapy that would prevent successful completion of the study. * subject has had a recent major cardiovascular adverse event within the last 3 months. * subject has a persistent pre-dialysis sitting systolic blood pressure less than 100 mmhg despite medical therapy. * subject has ongoing, symptomatic intra-dialytic hypotension requiring medical intervention. * subject has an active infection requiring antibiotics within the last 7 days. * subject with fluid overload due to intractable ascites secondary to liver cirrhosis. * subject is seroreactive for hepatitis b surface antigen. * subject has a history of adverse reactions to dialyzer membrane material. * subject is participating in another investigative drug or device clinical study related to dialysis which conflicts with the execution of this study. * subject is scheduled to receive an organ transplant during the course of the study: paired exchange or living donor. * subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol. * any other documented condition that the investigator feels would prevent the subject from successful inclusion in the study. * subject has an active viral infection (eg. covid-19). * subject is on peritoneal dialysis.

Keywords: hemodialysis
a study of fluzoparib±apatinib versus chemotherapy treatment of physician's choice in her2-negative metastatic breast cancer patients with germline brca mutation

Conditions: Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation

Summary: this is a multicenter, randomized, open-label, 3-arm phase 3 study to evaluate the efficacy and safety of fluzoparib alone or with apatinib versus physicians choice chemotherapy, as treatment, in patients with a germline brca mutation and her2-negative metastatic breast cancer. the study contains a safety lead-in phase in which the safety and tolerability of fluzoparib+apatinib will be assessed prior to the phase 3 portion of the study.


Eligibility criteria:
inclusion criteria: * （saftey lead-in + phase 3）germline mutation in brca1 or brca2 that is predicted to be deleterious or suspected deleterious * （saftey lead-in + phase 3）human epidermal growth factor receptor type 2 (her2)-negative metastatic breast cancer * （saftey lead-in + phase 3）had received ≤2 lines of chemotherapy for mbc * （saftey lead-in + phase 3）prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting. * er/pr breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy. * ecog performance status 0-1. * adequate bone marrow, kidney and liver function. exclusion criteria: * prior treatment with a poly (adp-ribose) polymerase (parp) inhibitor or apatinib * prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, dcis or stage i grade 1 endometrial cancer allowed * radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization * known to be human immunodeficiency virus positive * known active hepatitis c virus, or known active hepatitis b virus * untreated and/or uncontrolled brain metastases * pregnant or breast-feeding women
head to head comparison of azacitidine and decitabine in myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: in myelodysplastic syndrome, epigenetic treatments such as azacitidine and decitabine have been highlighted in phase 3 studies. however, as the 1st line treatment, it has not been evaluated the head to head comparison of two drugs. this study is a retrospective study to compare the efficacy of two drugs.

among 300 mds patient, 200 of them have been taking azacitidine and 100 of them have been taking decitabine. medical chart of these patients will be reviewed to assess the efficacy and safety between two agents.

Eligibility criteria:
inclusion criteria: * confirmed mds by bone marrow examination * receiving azacitidine and decitabine as a first line chemotherapy * adequate hepatic, cardiac, and renal function exclusion criteria: * previously treated with another anti-cancer therapy due to mds * not available for clinical information

Keywords: mds
telephone counseling to enhance the quality and safety of romantic and sexual relationships in people living and aging with hiv

Conditions: HIV Seropositivity

Summary: the purpose of this study is to determine if a brief behavioral intervention delivered over the telephone is effective at reducing occasions of condomless sex in persons living and aging with hiv.

estimated rates of condomless anal and vaginal intercourse among hiv-positive older adults remain high. brief motivational interventions delivered face-to-face have demonstrated efficacy at reducing condomless sex in hiv-positive persons. however, these interventions are not contextualized to the unique sexual health needs of hiv-positive older adults. further, many hiv-positive older adults have difficulty accessing face-to-face services due to transportation, stigma, and other barriers. telehealth interventions represent one delivery approach that overcomes such barriers.

Eligibility criteria:
inclusion criteria: * english speaking * have access to a landline or cellular telephone * be 50 years of age or older at some point during study participation * report engaging in one or more occasions of condomless anal and/or vaginal intercourse with an hiv-negative or unknown hiv serostatus sex partner in the 3 months prior to study enrollment. an exception to this criterion is participants whose hiv viral load is undetectable and whose only condomless sex is in the context of a monogamous sexual relationship with an hiv-negative partner. exclusion criteria: * active suicidal ideation as determined by the patient health questionnaire 9-item depression module

Keywords: hiv motivational interviewing telephone telehealth risky sex unprotected sex condoms older adults